Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

NCT05634148 | Completed Phase 3 DMC

• 1 other identifier: SFH-Dex Nasal
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Riker sedation-agitation score

  Assessment of emergence delirium after extubation. It has numbers from 1-7.

  60 minutes

Secondary Outcomes (4)

• Postoperative pain score

  60 minutes

• Opioid consumption

  60 minutes

• Adverse events

  60 minutes

• Duration of stay in PACU

  60 minutes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Patients in this group will receive intravenous dexmedetomidine before extubation

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Patients in this group will receive intravenous placebo (0.9 % saline) before extubation

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group

Also known as: Control

Control group; Dexmedetomidine group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively

You may not qualify if:

• We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anwar Huda, FRCA

  Security Forces Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: December 22, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

SA (1)